FDAClass IIJune 21, 2017

Arrow MAC Two-Lumen Central Venous Access Kit recall: Sterility Concern

Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter…

Why was Arrow MAC Two-Lumen Central Venous Access Kit recalled?

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Material number: CDC-11242-1A Device Listing D025760

Product
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter…
Recalling firm
Arrow International Inc
Quantity
27,485 units distributed in U.S., 4,371 units distributed internationally
Distribution
Worldwide Distribution - US (nationwide) and Canada
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls